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510(k) Data Aggregation

    K Number
    K133302
    Device Name
    FLEXMAP 3D
    Manufacturer
    LUMINEX CORP.
    Date Cleared
    2014-01-10

    (77 days)

    Product Code
    NSU
    Regulation Number
    862.2570
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMINEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminex® FLEXMAP 3D® system with xPONENT® software is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
    Device Description
    Not Found
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    K Number
    K121399
    Device Name
    LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
    Manufacturer
    LUMINEX CORP.
    Date Cleared
    2013-01-09

    (245 days)

    Product Code
    NSU
    Regulation Number
    862.2570
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMINEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
    Device Description
    Not Found
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    K Number
    K073506
    Device Name
    LUMINEX LX 100/200 INSTRUMENT
    Manufacturer
    LUMINEX CORP.
    Date Cleared
    2008-03-07

    (85 days)

    Product Code
    NSU
    Regulation Number
    862.2570
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMINEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminex LX 100/200 Instrument is a clinical multiplex test system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.
    Device Description
    The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.
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